- Amneal Pharmaceuticals (Piscataway, NJ)
- …submission of high quality, regulatory submissions such to the Food and Drug Administration ( FDA ) and other Health Authorities, as required, within company ... Regulatory Affairs Specialist, assists in the management of regulatory submissions to ( FDA ) and other Health...and managing the status of submissions under review with FDA as per the Generic Drug User… more
- Organon & Co. (Jersey City, NJ)
- …products, in order to optimize label and obtain shortest time to approval by regulatory agencies, including but not limited to US- FDA or EU procedures ... company with external organizations through direct communication with the FDA , EMA, or other EU regulatory agencies,...or EMA; prepare our company's teams for meetings with FDA or EMA at any phase of drug… more
- Ascendis Pharma (Princeton, NJ)
- …with prescription drug , biologic, and/or combination products; experience managing major regulatory filing(s) to the FDA Office of Prescription Drug ... regulations, guidance, and enforcement trends governing the promotion of prescription drug and biologic products. The Senior Manager Regulatory Affairs,… more
- RWJBarnabas Health (West Orange, NJ)
- …years of legal experience, including substantial experience with clinical research, FDA regulatory compliance, and research contracting + Comprehensive knowledge ... Assistant Vice President of Legal Affairs, Clinical Research & Regulatory ComplianceReq #:0000206242 Category:Professional / Management Status:Full-Time Shift:Day Facility:RWJBarnabas… more
- Kelly Services (Bridgewater, NJ)
- ** Regulatory Affairs Specialist - Advertising & Promotion** **Location:** Bridgewater, NJ / Hybrid **Pay Rate:** $61-$91/hour HYBRID **Overview:** We are seeking an ... experienced Regulatory Affairs Specialist with a focus on Advertising and...that all promotional activities adhere to applicable US laws, FDA regulations, and company policies, and collaborates cross-functionally to… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …involving FARs and recalls. Essential Functions: + Will be the contact person for the FDA and other regulatory agencies in regard to Field Alerts responses and ... Field Alert & Recall Compliance is responsible for overseeing regulatory activities related to Field Alert Reports (FARs), product...Notifications as well as completes and issues to Illegitimate Drug Notification 3911 forms to FDA as… more
- Sumitomo Pharma (Trenton, NJ)
- …Manages the planning, tracking, compiling, quality checking and submission of required FDA Submissions (eg Establishment Registrations, Drug Product Listings). + ... and procedures, including computer word processing, electronic document management systems, and regulatory publishing software. + Robust understanding of FDA and… more
- Edgewell Personal Care (Allendale, NJ)
- …+ Sound knowledge of the consumer products industry. + Experience with OTC drug regulations for FDA , Health Canada, and TGA. Medical devices's regulations ... the Global R&D organization who oversees all activities related to regulatory compliance across all Edgewell's brand portfolio. Responsible for assessing,… more
- Sumitomo Pharma (Trenton, NJ)
- …a working relationship with the Office of Prescription Drug Promotion (OPDP) at FDA . + Serve as internal regulatory expert on FDA regulations, guidance ... a dynamic, highly motivated, and experienced individual for the position of **Director, Regulatory Advertising & Promotion** . The Director is part of the Global … more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- … strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activities in alignment ... of the drug development process, laws, regulations, and guidelines including FDA , ICH, etc. - Able to successfully interpret and apply regulatory … more